Neostigmine Methylsulfate

ANDA 207042, held by Hikma. Neostigmine Methylsulfate.

As of Nov 15, 2026, ANDA 207042 (Neostigmine Methylsulfate), held by Hikma, was first approved by FDA on Dec 28, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 28, 2015
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Neostigmine Methylsulfate Injection, USP is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Neostigmine Methylsulfate Injection, USP, a cholinesterase inhibitor, is

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 28, 2015	Original application	Approved	Label Letter

Products

2 strengths and forms


Neostigmine Methylsulfate5MG/10ML (0.5MG/ML) · solution;intravenous	Neostigmine Methylsulfate	Rx
Neostigmine Methylsulfate10MG/10ML (1MG/ML) · solution;intravenous	Neostigmine Methylsulfate	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 8, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Dec 28, 2015	Original application	Approved	Label Letter

Identifiers

Application: ANDA 207042
Drugs@FDA: Overview at FDA
Company: Hikma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters